WFI Verification Engineer
Rocky Mount, NC
8+ months
You will be responsible for
Support project activities within a cross functional project team.
Define project strategy according to current standard operational procedures.
Perform verification activities to support water pretreatment systems, high quality steam
systems generation and distribution and water for injection systems start-up, commissioning
and qualification. This includes change control initiation, project planning, documentation
development and approval.
Participate in technical meetings with client and design/construction companies.
Control project progress and resource planning.
Follow standard operating procedures and standards in a highly regulated environment.
Support project team in protocol generation, revision, execution and approval.
Develop new standard operating procedures associated with the scope of work.
Contribute substantially to the interpretation of results and the design of subsequent project
phases.
Request, evaluate and share technical information with project team.
Perform all tasks in strict compliance with best practices and regulatory requirements.
Provide feedback to client leadership regarding potential issues and concerns with
documentation elaboration and tasks execution.
Adhere to safe work practices.
About you
Bachelor's degree in engineering, science or related field.
At least 10 years of experience in qualification activities for Pharmaceutical Industries.
Experience in commissioning and qualification activities related to water pretreatment systems,
high quality steam systems generation/distribution and water for injection systems
Ability to interpret engineering drawings and discuss technical solutions associated with WFI
systems.
Hands on experience in the development of Life Cycle documents such as Project Validation
Plans, User Requirement Specifications and Risk Assessments.
Hands on experience in the elaboration and execution of FAT, Commissioning, SAT, Installation
Qualification, Operational Qualification and Performance Qualification Protocols and
Qualification Reports.
Hands on experience in evaluation of welding activities, procedures and welding
documentation.
Hands on experience in the elaboration of Standard Operating Procedures for operation and
maintenance of WFI systems.
Strong understanding of FDA regulations for commissioning, validation, and lifecycle
management of GMP equipment and systems.
Knowledge in WFI guidelines from International Society of Pharmaceutical Engineering.
Ability to manage resource planning, priorities, deliverables, and project schedule milestones.
Strong interpersonal, verbal communication, and technical writing skills.
Fluency in English (reading, speaking and writing) is a must.
